SOURCE: DNAPrint Genomics, Inc.

February 14, 2006 07:00 ET

DNAPrint Pharmaceuticals Retains DOCRO for Development of Immunoassay to Better Detect Diabetic Vascular Complications

SARASOTA, FL -- (MARKET WIRE) -- February 14, 2006 -- DNAPrint Genomics, Inc. (OTC BB: DNAG) today announced that DOCRO, INC (DOCRO) has been retained to provide consulting and product development services to DNAPRINT PHARMACEUTICALS, Inc., its subsidiary drug and diagnostics development company. DOCRO will perform technical and clinical assistance and provide guidance on the regulatory requirements associated with the design of clinical trials necessary to commercialize DNAPrint's recently in-licensed intellectual property relating to glycated CD59. http://www.dnaprint.com/welcome/press/press_recent/2006/0126/DNAG-HARVARD.pdf

Glycated CD59 has shown promise as a potentially highly sensitive marker of the common complications of diabetes. These complications frequently result from obstruction of the small blood vessels that provide nutrients and oxygen to organs and tissues. At least 60% of diabetic patients will develop these and other life limiting complications, including renal failure due to microvascular damage in the kidney, blindness due to damage of blood vessels in the retina, and tissue death in the extremities due to damage of the nerves and obstruction of the arteries. Today, there is no test that directly measures or monitors the progressive damage caused by the intermittent high sugar -- glucose -- levels experienced by even well controlled diabetic patients. Current clinical diagnosis of these complications, based on symptoms or laboratory tests, often occurs only after the patient suffers irreversible consequences to their health. If the CD59 test proves to be a sensitive measure of early cellular and molecular events in the vessel damage process associated with diabetes, patients receiving the test may be treated earlier and the disease progression may be slowed or blunted.

Founded in 1996 and located in Seymour, Connecticut, DOCRO is a full service contract research organization (CRO) specializing in the design and conduct of clinical trials of in vitro diagnostic products attempting to gain marketing clearance or approval from the U.S. Food and Drug Administration. DOCRO offers complete clinical trial management, guidance on FDA regulatory procedures, and technology development.

"DOCRO is a leading CRO specializing in the commercialization of diagnostic technologies," commented Dr. Hector J. Gomez, MD, PhD, DNAPrint's Chairman and Chief Medical Officer of DNAPrint Genomics, Inc. and the newly formed DNAPrint Pharmaceuticals. "DOCRO's proven formula for success has resulted in an unparalleled track record at the FDA with over seventy consecutive successful FDA submissions."

"We are particularly impressed with DOCRO's success in managing clinical trials and their ability to provide the appropriate documents required by the FDA. DOCRO's commitment to quality and integrity has facilitated multiple successful FDA submissions and eventual market introductions of diagnostic tests. DOCRO's team will be an advantage as we navigate our CD59 test through the multiple steps of the FDA process," noted Chief Executive Officer Richard Gabriel.

"After seventy successful FDA submissions, DOCRO has had diverse and extensive experience with a wide variety of immunoassays and other diagnostic tests in many medical specialties and settings. We believe we can be a knowledgeable partner with DNAPrint Pharmaceuticals in helping develop this technology to help diabetic patients further understand and manage their health and well being," commented Thomas Soriano, President and CEO of DOCRO.

About DNAPrint Genomics, Inc.

DNAPrint Genomics, Inc. (www.dnaprint.com) is a developer of genomics-based products and services in two primary markets: biomedical and forensics. DNAPrint Pharmaceuticals, Inc., a wholly owned subsidiary, develops diagnostic tests and theranostic products (drug/test combinations) using the Company's proprietary ancestry-informed genetic marker studies combined with proprietary computational modeling technology. Computational Biology and Pharmacogenomics services are also offered externally to biopharmaceutical companies. The Company's first theranostic product is PT-401, a "Super EPO" (erythropoietin) dimer protein drug for treatment of anemia in renal dialysis patients (end stage renal disease). Pre-clinical and clinical development of all the Company's drug candidates will benefit from simulated pre-trials to better design actual trials and are targeted to patients with a genetic profile indicating their propensity to have the best clinical response. DNAPrint is proud of its continued dedication to developing and supplying new technological advances in law enforcement and consumer ancestry heritage interests. Please refer to www.dnaprint.com for information on law enforcement and consumer applications which include DNAWITNESS™, RETINOME™, ANCESTRYbyDNA™ and EURO-DNA™. DNAWitness-Y and DNAWitness-Mito are two tests offered by the Company. The results from these tests may be used as identification tools when a DNA sample is deteriorated or compromised or other DNA testing fails to yield acceptable results.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint's products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint Genomics, Inc. expressly disclaims any obligation or undertaking, except as may be required by applicable law or regulation, to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DNAPrint's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.

Contact Information

  • Company Contact:
    Richard Gabriel
    CEO and President
    941 366-3400
    or
    Ron Stabiner
    The Wall Street Group, Inc.
    212-888-4848